Erlotinib Teva 100 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

ERLOTINIBHYDROCHLORIDE SAMENSTELLING overeenkomend met ; ERLOTINIB

Beschikbaar vanaf:

Teva Nederland B.V.

ATC-code:

L01XE03

INN (Algemene Internationale Benaming):

ERLOTINIBHYDROCHLORIDE COMPOSITION corresponding to ; ERLOTINIB

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; NATRIUMZETMEELGLYCOLAAT ; PLANTAARDIGE OLIE, GEHYDREERD ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; NATRIUMZETMEELGLYCOLAAT (E468) ; PLANTAARDIGE OLIE, GEHYDREERD ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Erlotinib

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); LACTOSE 1-WATER; MACROGOL 4000; MAGNESIUMSTEARAAT (E 470b); NATRIUMLAURILSULFAAT (E 487); NATRIUMZETMEELGLYCOLAAT (E468); PLANTAARDIGE OLIE, GEHYDREERD; SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);

Autorisatie datum:

2017-04-06

Bijsluiter

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PACKAGE LEAFLET
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BIJSLUITER: INFORMATIE VOOR DE GEBRUIKER ERLOTINIB TEVA 25 MG, FILMOMHULDE TABLETTEN
ERLOTINIB TEVA 100 MG, FILMOMHULDE TABLETTEN
ERLOTINIG TEVA 150 MG, FILMOMHULDE TABLETTEN
Erlotinib
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
contains the active substance erlotinib.
is a medicine used to treat
cancer by preventing the activity of a protein called epidermal growth
factor receptor (EGFR). This
protein is known to be involved in the growth and spread of cancer
cells.
is indicated for adults. This medicine can be
prescribed to you if you have non-small
cell lung cancer at an advanced stage. It can be prescribed as initial
therapy or as therapy if your
disease remains largely unchanged after initial chemotherapy, provided
your cancer cells have specific
EGFR mutations. It can also be prescribed if previous chemotherapy has
not helped to stop your
disease.
This medicine can also be prescribed to you in combination with
another treatment called gemcitabine
if you have cancer of the pancreas at a metastatic stage.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DO NOT TAKE :

if you are allergic to erlotinib or any of the other ingre

Productkenmerken

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAAM VAN HET GENEESMIDDEL
Erlotinib Teva 25 mg, filmomhulde tabletten
Erlotinib Teva 100 mg, filmomhulde tabletten
Erlotinib Teva 150 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 25 mg erlotinib (as erlotinib
hydrochloride)
One film-coated tablet contains 100 mg erlotinib (as erlotinib
hydrochloride)
One film-coated tablet contains 150 mg erlotinib (as erlotinib
hydrochloride)
Excipients with known effect:
25 mg: Each film-coated tablet contains 14.745 mg lactose monohydrate.
100 mg: Each film-coated tablet contains 58.98 mg lactose monohydrate.
150 mg: Each film-coated tablet contains 88.47 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets
25 mg: White, round, biconvex tablets, with debossing
25 on one side and E on the
other side with dimensions of about 6.1 x 3.3 mm.
100 mg: White, round, biconvex tablets, with debossing
100E on one side with
dimensions of about 10.1 x 4.1 mm.
150 mg: White, round, biconvex tablets, with debossing
150E on one side with
dimensions of about 11.1 x 5.4 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Non-Small Cell Lung Cancer (NSCLC):
is indicated for the first-line treatment of patients
with locally advanced or metastatic
non-small cell lung cancer (NSCLC) with EGFR activating mutations.
is also indicated for switch maintenance treatment in
patients with locally advanced
or metastatic NSCLC with EGFR activating mutations and stable disease
after first-line chemotherapy.
is also indicated for the treatment of patients with
locally advanced or metastatic
NSCLC after failure of at least one prior chemotherapy regimen.
When prescribing , factors associated with prolonged
survival should be taken into
account.
No survival benefit or other clinically relevant effects of the
treatment have been demonstrated in
pa